Registry Study for Proton Therapy Outcomes

This study is currently recruiting participants.
Verified December 2012 by Proton Collaborative Group
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group
ClinicalTrials.gov Identifier:
NCT01255748
First received: December 6, 2010
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

The purpose of this research study is to collect and analyze information from patients being treated with proton therapy.


Condition Intervention
Solid Tumors
Radiation: Proton Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation Tracking Project: A Prospective Chart Review of Patients Treated With Proton Therapy

Resource links provided by NLM:


Further study details as provided by Proton Collaborative Group:

Primary Outcome Measures:
  • Define outcomes for patients treated at participating institutions [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine strategies necessary to improve patients outcome and decrease toxicities related to treatments and procedures [ Time Frame: Annually PRN ] [ Designated as safety issue: Yes ]
  • Improve patient care by an adequate understanding of the results and patient population at participating institutions [ Time Frame: Reviewed Annually PRN ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: June 2009
Groups/Cohorts Assigned Interventions
Treatment with Proton Therapy Radiation: Proton Therapy
Outcomes Tracking

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Planned treatment with proton radiation
  • Ability to understand and sign IRB approved consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255748

Contacts
Contact: Kimberly Hahn, RN, CCRP 812-330-6653 kim.hahn@pcgresearch.org
Contact: Angela Piper, MBA 765-327-0344 angela.piper@pcgresearch.org

Locations
United States, Illinois
ProCure Proton Therapy Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Lori Abruscato, BS     630-821-6397     lori.abruscato@chi.procure.com    
Principal Investigator: William Hartsell, MD            
United States, New Jersey
ProCure Proton Therapy Center Recruiting
Somerset, New Jersey, United States, 08873
Contact: Nina Sullivan, RN     732-357-2626     nina.sullivan@nj.procure.com    
Principal Investigator: Brian Chon, MD            
United States, Oklahoma
ProCure Treatment Centers, Inc. Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Sameer Keole, MD     405-773-6722     Sameer.Keole@okc.procure.com    
Contact: Tisha Adams, MS, CCRC     405-773-6775     tisha.adams@okc.procure.com    
Principal Investigator: Sameer Keole, MD            
Sponsors and Collaborators
Proton Collaborative Group
Investigators
Study Chair: Carlos Vargas, MD Proton Collaborative Group
  More Information

No publications provided

Responsible Party: Proton Collaborative Group
ClinicalTrials.gov Identifier: NCT01255748     History of Changes
Other Study ID Numbers: REG001-09
Study First Received: December 6, 2010
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Proton Collaborative Group:
cancer, proton, radiation

ClinicalTrials.gov processed this record on May 19, 2013